NCT01407978

Tolerability and Immunogenicity Study of FLUVAL P H1N1 Flu Vaccine of Omninvest in Children and Adolescents

Tolerability and Immunogenicity Study of FLUVAL P H1N1 Monovalent Influenza Vaccine of Omninvest in Children and Adolescents

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Fluart Innovative Vaccine Ltd, Hungary · Industry
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Accepted

Summary

This is a single-blind, reference drug controlled study to assess safety and tolerability of FLUVAL P H1N1 monovalent influenza vaccine (whole virus, inactivated, adjuvanted with alumn phosphate gel) containing 6 mcgHA per 0.5mL active ingredient in children and adolescents. To assess, as secondary objective, the efficacy (immunogenicity) of the vaccine by serology testing.

Detailed description

Primary Objective: * To assess tolerability/safety (incidence of adverse events 21-28 days following vaccination) of the study drug. Secondary Objectives: * To assess the efficacy (immunogenicity) of the study drug by serology testing of blood samples taken at Day 21-28 after immunization in groups and age groups. * To assess long term (180-210 days following vaccination) tolerability/safety (incidence of adverse events) of the study drug.

Conditions

• Novel 2009 Influenza H1N1
• Influenza, Human

Interventions

Type	Name	Description
BIOLOGICAL	Vaccination with Fluval P monovalent influenza vaccine	* Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant. * Dose: 0.25 ml /total 3 μg HA/ in age group 3-12 years, and 0.5 ml /total 6 μg HA/ in age group 12-18 years, single dose.
BIOLOGICAL	Vaccination with Fluval AB	* Vaccination with Fluval AB trivalent influenza vaccine with 15 μg HA/0.5ml/strain active ingredient content and aluminium phosphate gel adjuvant. * Dose: 0.25 ml /total 3x7.5 μg HA/ in age group 3-12 years, 0.5 ml /total 3x15 μg HA/ in age group 12-18 years, single dose.
BIOLOGICAL	Vaccination with Fluval AB Novo	* Vaccination with Fluval AB Novo trivalent influenza vaccine with 6 μg HA/0.5ml/strain active ingredient content and aluminium phosphate gel adjuvant. * Dose: 0.25 ml /total 3x3 μg HA/ in age group 3-12 years, 0.5 ml /total 3x6 μg HA/ in age group 12-18 years, single dose.

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2011-08-02
• Last updated: 2012-05-21

Locations

1 site across 1 country: Hungary